Saturday, February 16, 2013

Why Greys Anatomy is a Bad Place to Promote Device Research

For medical students, residents, and attendings aspiring to develop a new medical device that is FDA approved for patient use, there are a few things you should remember:

First, don't star in Grey's Anatomy while your experimental device is demonstrated by faux doctors performing faux procedures on faux patients. People might think you are a faux doctor helping the other faux doctors install a faux heart failure device.

Second, in your excitement after the shoot, avoid saying things to main stream media like: "This kind of attention is important to create awareness and to help people that are out there that have a heart problem and have been given no option of therapy to learn that there is an option." Really don't say this after your FDA trial has begun in "Kansas, Kentucky and Ohio." Statements like those might run afoul of the FDA guidance statement for the recruitment of study subjects.

Third, don't have the actors describe the device as "crazyballs." Because the device is experimental and hasn't even completed clinical testing and evaluation in the US, such a claim might fly in the face of FTC deceptive advertising guidelines.

4 comments:

Anonymous
said...

The real doctors fall under the prior post "The Exodus Begins" Who wouldn't try to get out of medicine at this time? It is a lot easier to sit around a board room and devise new ways to regulate than to be the one regulated. Entering industry is just as good as going into administration. Anything to avoid pulling charts off a door.

To first anonymous,not necessarily.. how many times during my career in education did I hear an administrator say during my evaluation, " Oh, watching you teach makes me yearn to be in the classroom again." Um, no it doesn't or else you would still be there. " But I can do so much more for the children from an administrative position." Hmm... really? Not to mention the big salary, higher value life insurance policy, matching pension pickup, window air conditioners which would cost too much installed in every classroom, including the interior rooms. In short, nah, I don't think ALL of the best doctors have jumped ship, and I am hoping when my time comes to stick some body part into the medical pool, that I luck out and get someone with knowledge and humility.

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About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.